AsthmaNCT01003340
A Community Health Worker Home Intervention to Improve Pediatric Asthma Outcomes
A study testing Wee Wheezers in people with Asthma, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The investigators propose to test the hypothesis that a home-based asthma intervention, the Wee Wheezers program, delivered by the Community Health Workers and tailored to the needs of the investigators community, will improve anti-inflammatory medication adherence, parental asthma knowledge and management behaviors… Read more about this study
- Who is it for?
- Ages 2 to 9 years
- Conditions the study is for
- Asthma
- What is being tested?
- Wee Wheezers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children 2-9 years of age with persistent asthma
- children being currently prescribed ICS in the Metered Dose Inhaler (MDI) form
- if the child is 2 years of age at the time of the recruitment, he/she must have at least two prior episodes of wheezing treated and reversible with beta-agonists
- primary caregiver speaks English or Spanish
- family has a phone.
Who cannot join
- children with other chronic pulmonary diseases (e.g, cystic fibrosis, bronchopulmonary dysplasia) or presence of tracheostomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Group- CHCC
The Bronx, New York, 10451
About this study
Official title: A Randomized Controlled Trial of a Community Health Worker Home-Based Asthma Intervention
The investigators propose to test the hypothesis that a home-based asthma intervention, the Wee Wheezers program, delivered by the Community Health Workers and tailored to the needs of the investigators community, will improve anti-inflammatory medication adherence, parental asthma knowledge and management behaviors, which in turn will reduce asthma morbidity (defined as days with asthma symptoms) and health care utilization (defined as asthma-related Emergency Department visits) among low-income, minority children with persistent asthma in the Bronx.
Read the detailed description
Asthma disproportionately burdens low-income inner city and minority children residing in inner cities. Daily use of inhaled corticosteroids (ICS) control symptoms and reduce asthma morbidity. Less then 50% of children with persistent asthma adhere to such therapy. Poor adherence to ICS medications is one of the major contributors to asthma morbidity. One way to reduce asthma disparities is to work in partnership with communities. Community Health Workers (CHWs) share the ethnic, cultural, social, and environmental experiences of the people in the community. Although, CHW home interventions have been successful in reducing asthma allergens, no studies using CHWs to deliver a previously identified evidence-based home intervention to improve ICS adherence and health outcomes in a population of inner-city, minority children with persistent asthma have been found. Objective: To evaluate the effectiveness of an evidence-based asthma home intervention, the Wee Wheezers program, tailored to the needs of the community and delivered by CHWs, in improving medication adherence, health outcomes and parental management behaviors among low-income, minority children with persistent asthma in the Bronx.
- Conditions
- Asthma
- Being tested
- Wee Wheezers
- Keywords
- asthma, children, community health workers, home intervention
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wee WheezersBehavioural
Also called Wee Wheezers at Home
The intervention, Wee Wheezers, modified to the needs of the targeted population will include 6 bi-weekly 1 hour educational home visits conducted by Community Health Workers at homes of children with persistent asthma
| Study group | Role | What they receive |
|---|---|---|
| Wee Wheezers asthma education | Experimental | 6 lesson asthma education delivered at home by Community Health Workers Receives: Behavioral: Wee Wheezers |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean number of asthma symptom days
average of asthma symptom days
Measured: baseline and every 8 weeks during the 12-months study period
Secondary outcomes (3)
adherence to Inhaled Corticosteroid
survey evaluating medication adherence
Measured: baseline, 4 weeks, 8 weeks, and 12 weeks after beginning of intervention
asthma-related Emergency Department visits
number of ED visits
Measured: baseline, 3-, 6- and 12-months follow-up
parental asthma knowledge and management behaviors
survey evaluating asthma knowledge and management behavior
Measured: baseline, 3-, 6- and 12-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Lung Association
- Responsible party
- Principal investigator, Marina Reznik, Montefiore Medical Center
- Investigators
- Marina Reznik, MD, MS, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003340
- Sponsor's protocol ID
- 07-10-360
- Other IDs
- CG-120837-N
- Status last verified
- Feb 2018
- First submitted
- 27 Oct 2009
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Reznik M, Ozuah PO. Measurement of inhaled corticosteroid adherence in inner-city, minority children with persistent asthma by parental report and integrated dose counter. J Allergy (Cairo). 2012;2012:570850. doi: 10.1155/2012/570850. Epub 2012 Mar 15.
PubMed 22505947Reznik M, Silver EJ, Cao Y. Evaluation of MDI-spacer utilization and technique in caregivers of urban minority children with persistent asthma. J Asthma. 2014 Mar;51(2):149-54. doi: 10.3109/02770903.2013.854379. Epub 2013 Oct 22.
PubMed 24131031Reznik M, Jaramillo Y, Wylie-Rosett J. Demonstrating and assessing metered-dose inhaler-spacer technique: pediatric care providers' self-reported practices and perceived barriers. Clin Pediatr (Phila). 2014 Mar;53(3):270-6. doi: 10.1177/0009922813512521. Epub 2013 Dec 12.
PubMed 24336438
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Community Health Worker Home-Based Asthma Intervention
- ClinicalTrials.gov ID
- NCT01003340
- Acronym / sponsor ID
- 07-10-360
- Conditions
- Asthma
- Keywords
- asthma, children, community health workers, home intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- American Lung Association
- Study start
- Jul 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 28 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose to test the hypothesis that a home-based asthma intervention, the Wee Wheezers program, delivered by the Community Health Workers and tailored to the needs of the investigators community, will improve anti-inflammatory medication adherence, parental asthma knowledge and management behaviors, which in turn will reduce asthma morbidity (defined as days with asthma symptoms) and health care utilization (defined as asthma-related Emergency Department visits) among low-income, minority children with persistent asthma in the Bronx.
Detailed description
Asthma disproportionately burdens low-income inner city and minority children residing in inner cities. Daily use of inhaled corticosteroids (ICS) control symptoms and reduce asthma morbidity. Less then 50% of children with persistent asthma adhere to such therapy. Poor adherence to ICS medications is one of the major contributors to asthma morbidity. One way to reduce asthma disparities is to work in partnership with communities. Community Health Workers (CHWs) share the ethnic, cultural, social, and environmental experiences of the people in the community. Although, CHW home interventions have been successful in reducing asthma allergens, no studies using CHWs to deliver a previously identified evidence-based home intervention to improve ICS adherence and health outcomes in a population of inner-city, minority children with persistent asthma have been found. Objective: To evaluate the effectiveness of an evidence-based asthma home intervention, the Wee Wheezers program, tailored to the needs of the community and delivered by CHWs, in improving medication adherence, health outcomes and parental management behaviors among low-income, minority children with persistent asthma in the Bronx.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wee Wheezers asthma education | Experimental | Behavioral: Wee Wheezers6 lesson asthma education delivered at home by Community Health Workers |
Who may qualify
- Ages
- 2 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- children 2-9 years of age with persistent asthma
- children being currently prescribed ICS in the Metered Dose Inhaler (MDI) form
- if the child is 2 years of age at the time of the recruitment, he/she must have at least two prior episodes of wheezing treated and reversible with beta-agonists
- primary caregiver speaks English or Spanish
- family has a phone.
Key exclusion criteria (1 listed)
- children with other chronic pulmonary diseases (e.g, cystic fibrosis, bronchopulmonary dysplasia) or presence of tracheostomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wee WheezersAlso: Wee Wheezers at HomeThe intervention, Wee Wheezers, modified to the needs of the targeted population will include 6 bi-weekly 1 hour educational home visits conducted by Community Health Workers at homes of children with persistent asthma | Behavioural | Wee Wheezers asthma education |
Primary outcome
mean number of asthma symptom days
Time frame: baseline and every 8 weeks during the 12-months study period
average of asthma symptom days
3 secondary outcomes
adherence to Inhaled Corticosteroid
Time frame: baseline, 4 weeks, 8 weeks, and 12 weeks after beginning of intervention
asthma-related Emergency Department visits
Time frame: baseline, 3-, 6- and 12-months follow-up
parental asthma knowledge and management behaviors
Time frame: baseline, 3-, 6- and 12-months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
- Results publication: PubMed 22505947Reznik M, Ozuah PO. Measurement of inhaled corticosteroid adherence in inner-city, minority children with persistent asthma by parental report and integrated dose counter. J Allergy (Cairo). 2012;2012:570850. doi: 10.1155/2012/570850. Epub 2012 Mar 15.
- Results publication: PubMed 24131031Reznik M, Silver EJ, Cao Y. Evaluation of MDI-spacer utilization and technique in caregivers of urban minority children with persistent asthma. J Asthma. 2014 Mar;51(2):149-54. doi: 10.3109/02770903.2013.854379. Epub 2013 Oct 22.
- Results publication: PubMed 24336438Reznik M, Jaramillo Y, Wylie-Rosett J. Demonstrating and assessing metered-dose inhaler-spacer technique: pediatric care providers' self-reported practices and perceived barriers. Clin Pediatr (Phila). 2014 Mar;53(3):270-6. doi: 10.1177/0009922813512521. Epub 2013 Dec 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina Reznik, MD, MS principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wee Wheezers in people with Asthma, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean number of asthma symptom days (time frame: baseline and every 8 weeks during the 12-months study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01003340, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2018.